Senior Operator - Packing

InvaGen Pharmaceuticals Inc; Rangpo; On-site; INR 180,000 - 240,000; Full time

Job summary

InvaGen Pharmaceuticals Inc. is seeking a Packing Operator to operate and maintain packing machines, ensuring quality product and on-time batch processing in a manufacturing setup.

The role requires 0-2 years of packing experience, with knowledge of QMS documents, SOPs, and safety practices. Diploma in Engineering or Pharmacy preferred; training will cover cGMP and process improvements.

Qualifications

• Diploma required (Engineering or Pharmacy).
• 0-2 years of experience in packing with knowledge of QMS activities, qualification and related documents.
• Must follow SOPs, safety guidelines and maintain quality standards.

Responsibilities

• Prepare machine for packing as per production plan with available resources.
• Calibrate, clean and set equipment per SOP/schedules for on-time batches.
• Operate packing machines with minimal resources to ensure quality output.
• Perform in-process checks, labeling, and rejection control.
• Maintain equipment, facility and line clearance for audit readiness and safety.
• Update online documentation to meet cGMP; fill logs and related records.

Skills

Packing operations

cGMP compliance

SOP adherence

Documentation

Education

Diploma in Engineering or Pharmacy

Job description

Job Description:

Division

Department

Sub Department 1

Job Purpose

Operate & maintain packing machines to achieve quality product & shift wise targeted output with maximum utilisation.

Key Accountabilities (1/6)

Prepare the machine for packing operation as per production plan by using proper resources to ensure smooth operations

Perform calibration, clean and set different equipment and machines as per SOP and schedules for on-time completion of batch processing

Check the suitable change part as per product requirement

Arrange change parts & stereo for batch packing activity

Key Accountabilities (2/6)

Operate the packing machines by using minimum resources to get quality product

Evaluate the product dimensions and set the machine for changeovers

Perform in-process checks in packing machines to ensure proper functioning of machine

Perform labelling and handle rejection control in packing machine

Reduce micro stoppages and avoid non-conformances during packing machine operations, cleaning and line clearance

Maintain equipment, facility and block premises as per SOP for audit readiness and to avoid critical and major observation

Perform all operations as per cGMP and safety to reduce rejection

Key Accountabilities (3/6)

Execute and update online documentation to meet cGMP requirements and maintain data integrity Fill Machine logs. Document entries/SOP and process simplification to meet cGMP.

Fill Machine logs & other relevant documents precisely to meet cGMP requirements

Check documentation before submission to ensure data integrity

Conduct training related to cGMP, equipment operation, for workmen to minimize deviation from procedure

Provide technical support to operators about packing activity and cGMP to get quality output for any up-gradation during packing activity

Key Accountabilities (4/6)

Perform packing machine operations safely to avoid safety incidences by appropriately handling the machines and thereby maintaining high standard of safety

Perform regular interlock checks of packing machines and perform safe operations

Ensure usage and maintenance of PPEs by workmen during shifts

Report any near-miss to officer in-charge in time

Key Accountabilities (5/6)

Deliver training to workmen and adhere cGMPand safety guidelines in production process to ensure smooth operations

Provide training to other operators about secondary packing machine settings and operations

Conduct training related to safety and housekeepingfor workmen

Participate in learning of new machine and build expertise in troubleshooting the machines

Key Accountabilities (6/6)

Major Challenges

Meeting shift target due to unavailability of adequate resources. Overcome by efficient work load distribution

Maintaining cGMP requirements during system downtime. Overcome by coordinating with engineering and technical support team

Low yield due to more rejections. Overcome by controlling rejection and simplification of process and attending training

Key Interactions (1/2)

Store for daily dispensing plan and availability of packing materials (Daily basis)

Engineering for preventive maintenance and help in modification (as per need)

Key Interactions (2/2)

Maintenance contractor for any machine repairs (Need Based)

Dimensions (1/2)

Achieve average volume of 60 mn (FY2015-16)

Average number of BPR’s handled : 60

Average number of batches in packing : 60

Average number of sales order dispatched : 25

Achieve internal OTIF more than 90%

Achieve Zero reportable accidents/ incidences during packing activities

Achieve 0% errors in online documentation

Meet 100% compliance to SOP and Safety regulation

Dimensions (2/2)

Key Decisions (1/2)

Up-gradation in facility and documents to Section Head - Packing

Modification in equipment to Section Head - Packing

Deviation and implementation of CAPAs Section Head - Packing

Key Decisions (2/2)

Education Qualification

Diploma (Engineering / Pharmacy)

Relevant Work Experience

0-2 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents